According to an article in the Journal of the American Academy of Dermatology (October 2001, pages 515-519), “The Food and Drug Administration (FDA) has received reports of depression and suicide in patients treated with [Accutane],… [F]rom 1982 to May 2000 the FDA received reports of 37 US patients treated with [Accutane] who committed suicide; 110 who were hospitalized for depression, suicidal ideation, or suicide attempt; and 284 with nonhospitalized depression, for a total of 431 patients. Factors suggesting a possible association between [Accutane] and depression include a [limited time] association between
use of the drug and depression_____ Compared with all drugs in the FDA’s Adverse Event
Reporting System database to June 2000, [Accutane] ranked within the top 10 for number of reports of depression and suicide attempt.”
In contrast to this report, a paper presented at the 59 th Annual Meeting of the American Academy of Dermatology (March 27, 2001, Washington, DC) stated that “Up to the current time, a rate of 12 suicides per 8 million isotretinoin-treated patients has been documented. Half of these patients were on concomitant [other] medications. A small number of patients have reported that depression subsided when isotretinoin was withdrawn and recurred with treatment resumption. In the United States, 64 suicides occurred between 1991 and 1999 in patients who at one time took isotretinoin. Thirty occurred during treatment, 24 after treatment was stopped (6 months to 10 years), and 10 occurred in patients whose treatment status was unknown.
“These numbers must be compared with general suicide statistics in the United States. In total, 30,000 suicides occur per year (in the general population, the rate is 11.4 per 100,000). Eighty percent are males. Suicide is the third leading cause of death in the 15- to 24-year age group (6000 per year). So when isotretinoin patients are observed, the 64 total suicides must be compared with an expected suicide rate of more than 10 times that number (670). These data suggest that in these patients the suicides were likely due to factors other than isotretinoin treatment. The isotretinoin suicide rate of 1.8 per 100,000 is well below that of the general population, as noted above. In addition, in the isotretinoin patients, there was no alteration in the typical US pattern of suicide in terms of gender distribution, relationship to depression, underlying psychiatric disorders, or lack of warning signs (typical of youth suicide).”
Further research confirming that Accutane is not associated with depression concluded that there was no increase in depressive and anxiety symptoms in the isotretinoin treatment group compared to that in the topical [acne medication] group. Instead, successful treatment of acne seems to improve both depressive and anxiety symptoms as well as improving quality of life. (Sources: International Journal of Dermatology, January 2009, pages 41-46; and Archives of Dermatology, May 2005, pages 557-560.)
Despite the controversy, Hoffman-La Roche, the makers of Accutane, is adding a warning about depression to the product information insert. Hoffman-La Roche is also removing copy from their ads that suggests Accutane can relieve the “psychological trauma” and “emotional suffering” associated with acne. The lengthy package insert for Accutane did include warnings about depression but not about possible suicide or psychosis.
As is true with any medication, all the pros and cons must be considered before starting treatment. If you or the teen you are responsible for already have a history of depression, then the potential for exacerbated depression must be taken into account and discussed with your physician.